...... 22-24 25-37 Other Biographical Sketches (Not to exceed four pages for each- See instructions J) ........................ Resources ................................................................................................................................................. 38-47 Page Numbers 1 Research Plan Introduction to Revised Application (Not to exceed 3 pages) ......................................................................................................... N/A Introduction to Supplemental Application (Not to exceed one page) .............................................................................................. N/A 49 A.B.Specific Aims ........................................................................ _,] .................................................................................... ._ Background and Significance ............................................................................................................................................ 49-53 / / C. 53-61 Preliminary Studies/Progress Report/ _- (Items A-D: not to exceed 25 pages*) ,_ N/A Phase I Progress Report (SBIR/STTR Phase II ONLY) | * SBIR/STTR Phase/: Items A-D limited to 15 pages. | D. Research Design and Methods .....................................................-.-.J............................................................................... [unreadable] 61-73 E. Human Subjects ................................................................................................................................................................ 73-79 Protection of Human Subjects (Required if Item 4 on the Face Page is marked '_(es") 74-76 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................ 76 Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") .............................................................. 76-77 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................ 77 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" an._da Phase I, II, or III clinical trial is proposed ...................................................................................................................................................... 77-79 F. Vertebrate Animals ............................................................................................................................................................ N/A G. Literature Cited .................................................................................................................................................................. 79-84 H. Consortium/Contractual Arrangements .............................................................................................................................. 84-85 I. Letters of Support (e.g., Consultants) ................................................................................................................................. 85-97 J. Product Development Plan (SBIPJSTTR Phase II and Fast-Track ONLY) ......................................................................... N/A Checklist .................................................................................................................................................... 98 Appendix (Five collated sets. No page numbering necessary for Appendix.) Check if Appendix is Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically soficited. Included Number of publications and manuscripts accepted for publication (not to exceed 10) 10 Other items (list): Appendix A South Africa Surveillance on AIDS, HIV and Substance Abuse Appendix B Materials from South Africa Pilot Study Appendix C Proposed Materials for the Western Cape Study Appendix D Articles PHS 398 (Rev. 05/01) Page 3 Form Page 3